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AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Join our study on preventing abdominal aortic aneurysm expansion.

Recruiting
18 years and older
All
Phase N/A
**Abdominal Aortic Aneurysm (AAA) Study Overview** This study looks at how safe and effective a new product called **IMPEDE-FX RapidFill** is for shrinking a bulge in a large blood vessel in the tummy area, called an **abdominal aortic aneurysm (AAA)**. This product is used along with a common procedure called **endovascular aneurysm repair (EVAR)**, which involves placing a stent (a tube-like device) to support the weakened blood vessel. The study is for people who need this procedure and meet certain health criteria. **Eligibility Criteria**: Participants must be 18 or older and eligible for the EVAR procedure on an aneurysm of a certain size. They should not have more than half of the aneurysm filled with a clot, and the bulge must be a specific size. Certain health problems or participation in other studies may exclude someone from joining. **Key Points**: - **Length and Visits**: Regular follow-ups are needed to check on the aneurysm and overall health after the procedure. - **Risks**: Standard risks associated with stent placement and any additional risks from using the new product. - **Compensation**: Participants may receive compensation for time and travel expenses. This study helps understand if this new product can help make aneurysms smaller in a safe way.
Study details
    Aortic Aneurysm
    Abdominal

NCT06029660

Shape Memory Medical, Inc.

26 April 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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